JPRN-UMIN000044118尚未招募未知
Boron neutron capture therapy using cyclotron-based epithermal neutron source for squamous cell carcinoma of the head and neck refractory to standard treatments: An open-label phase II trial - REBIVAL study
Department of Radiation Oncology, Southern Tohoku BNCT Research Center0 个研究点目标入组 120 人开始时间: 2021年5月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients (Pts) with active multiple cancers, not including lesions equivalent to carcinoma in situ or skin cancer considered healed 2. Pts with distant metastasis 3. Pts with active infections requiring systemic treatment 4. Pts with significant complications - Poorly uncontrolled diabetes - Poorly uncontrolled hypertension - Chronic lung disease - Kidney disease - Heart disease - Serious complications 5. Pts with phenylketonuria 6. Pts with hereditary fructose intolerance 7. Pts who have complications and a medical history with severe hypersensitivity reactions in drugs and contrast agents 8. Pts with myocardial infarction, unstable angina, uncontrolled arrhythmia within 6 months 9. Pts with over Grade 3 (CTCAE v4.0) in the target lesion site 10. Pts with the tumors invade the carotid artery or adjacent to more than halfway through the carotid artery, and considered not to manage the normal tissue between the carotid artery and membrane mucosa or skin by the treatments 11. Pts with decayed and untreated teeth 12. Pts with the administration of antineoplastic drug within 3weeks prior to the scheduled date of BNCT 13. Pts who were enrolled in unapproved drugs clinical study except for 18F-FBPA-PET/CT or who are participating in this clinical study within 4 weeks prior to the scheduled date of BNCT. Or patients will participate in unapproved drugs clinical study except for 18F-FBPA-PET/CT other clinical study during this study 14. Pts who have a cardiac pacemaker and auxiliary artificial heart 15. Pts who are considered unable to be fixed position during irradiation 16. Pts who complicated with psychiatric disorder or mental manifestation 17. Pts with poorly uncontrolled epilepsy 18. Pts who unable to comply with this clinical protocol and receive follow-up care 19. Other conditions that in the opinion of the investigator would preclude the subject's participation in a clinical study
研究者
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